Cross-reactivity of insulin analogues with three insulin assays
Cross-reactivity of insulin analogues with three insulin assays
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DOI：
10.1177/0004563214551613
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发表时间：
2015-05-01
影响因子：
2.2
通讯作者：
Perez Valero, V.
中科院分区：
文献类型：
--
作者：
Dayaldasani, A.;Rodriguez Espinosa, M.;Perez Valero, V.
背景免疫测定法在检测人胰岛素方面比放射免疫测定法具有更高的特异性，与胰岛素原或C肽几乎没有交叉反应。然而，市场上新的胰岛素类似物的引入已经提出了在这些测定中定义其交叉反应性的需要。几项研究已发表在这方面与不同的result.Methods研究的类似物是赖脯胰岛素，门冬胰岛素，甘精胰岛素，地特胰岛素和赖谷胰岛素。使用Immulite（R）2000和Advia Centaur（R）XP（西门子医疗诊断公司）和Elecsys（R）Modular Analytics E170（罗氏）测量胰岛素浓度。按照随机顺序，在同一分析运行中对所有样品进行15次处理。使用增加浓度的类似物对显示胰岛素浓度具有统计学和临床显著性变化的那些样品进行再处理，并且使用两种不同的血清池进行两次，一种具有低浓度胰岛素，一种具有高浓度胰岛素。（平均浓度与偏好变化值的比较：59.8%），并且干扰随着类似物浓度的增加而增加;在其他类似物的情况下，差异不显著。在Advia Centaur（R）和Immulite（R）2000中，仅谷赖胰岛素的结果不具有显著性（百分比差异44.7%
Background Immunometric assays have recently shown higher specificity in the detection of human insulin than radioimmunoassays with almost no cross-reaction with proinsulin or C peptide. The introduction of the new insulin analogues on the market, however, has raised the need to define their cross-reactivity in these assays. Several studies have been published in this regard with different results.Methods The analogues studied were insulins lispro, aspart, glargine, detemir, and glulisine. Insulin concentrations were measured in Immulite (R) 2000 and Advia Centaur (R) XP (Siemens Healthcare Diagnostics), and Elecsys (R) Modular Analytics E170 (Roche). All samples were processed 15 times in the same analytical run following a random sequence. Those samples which showed statistically and clinically significant changes in insulin concentration were reprocessed using increasing concentrations of analogue, and this was done twice, using two different serum pools, one with a low concentration of insulin and one with a high concentration of insulin.Results In the Elecsys (R) E170 analyser, glargine showed statistical changes (comparison of mean concentrations with preference change value: 59.8%), and the interference increased with increasing concentrations of analogue; the differences were not significant in the case of the other analogues. In the Advia Centaur (R) and Immulite (R) 2000 only the results for glulisine did not present significance (percentage difference 44.7%